Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

ISO 80369-1:2018 This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.

This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These healthcare fields include, but are not limited to:

- breathing systems and driving gases;

- enteral;

- limb cuff inflation;

- neuraxial;

- intravascular or hypodermic.

This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.

This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

NOTE 1 Clause 7 allows for ad